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New Endosuture Instrument System for flexible endoscopic suturing in the GI-tract

Karl-Hermann Fuchs, MD, Kai Neki, MD, A Lee, MD, R Dominguez Profeta, MD, R Broderick, MD, B Sandler, MD, Santiago Horgan, Prof. UC San Diego

Objective: Therapeutic endoscopy such as endoscopic tumor resections in the GI tract may be facilitated by more advanced instruments for dissecting and suturing. In the past, several complex multitasking platforms to fulfill these tasks were developed; none have achieved routine clinical application. Our group has focused on developing an endoscopic suturing technique using a standard flexible pediatric endoscope with new, Fortimedix Surgical designed, instruments allowing for complex end-effector movements. Aim: Perform flexible endoscopic suturing using a standard flexible scope in the GI tract

Methods: A standard flexible pediatric endoscope and a standard gastroscope were used for testing the new technique. Via an overtube, the endoscope and newly designed Fortimedix Surgical flexible instruments (needle holder; grasper) with a diameter of 5mm were inserted into the esophagus. The overtube (outer diameter 18.5 mm) permitted safe passage through the pharynx. Suture training was performed in an experimental setting in a box in the dry lab, followed by the pig-model. The flexible needle holder was advanced into the esophagus next to the scope, and a suture of the esophageal wall was performed, followed by extracorporeal knot-tying with 3 knots. The test series consisted of training with both resident trainees and surgeons to evaluate the learning curve. Each participant performed sutures on the box model and in the pig-esophagus. Feasibility, duration of the different steps, and handling problems were documented.

Results: Test series 01 (box training on esophago-gastric explant) with prototype 01 showed good feasibility. Suturing was possible in 9 out of 10 attempts. Median duration for single bite: 6 min (5-30); knot-tying: 5 min (2-8). Test series 02 (training in pig-model) with prototype 02 showed improved feasibility with better flexibility of instrument shaft: Median duration of double bite: 8 min (7-15); knot-tying: 2 min (1-5), overall duration intraluminal esophageal double bite suture and closing with 3 knots: median duration: 13 min (12-20).

Conclusions: The new Fortimedix Surgical Endosuture instruments seem feasible to use and perform dependable intraluminal sutures. The training period and learning curve is short and the objective is to apply this system clinically for closure of perforations and fistulas.


Presented at the SAGES 2017 Annual Meeting in Houston, TX.

Abstract ID: 98819

Program Number: ETP739

Presentation Session: Emerging Technology Poster Session (Non CME)

Presentation Type: Poster

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